Medical Devices & Pharma: FDA 21 CFR Part 11 & FEFO Traceability

codeunit 50250 "FDA Part 11 E-Signature Engine"
{
    Access = Public;
    Subtype = Normal;

    procedure ValidateQualityRelease(BatchNo: Code[20]; InspectorUserID: Code[50]; PasswordHash: Text): Boolean
    var
        UserSetup: Record "User Setup";
        BatchQualityRecord: Record "Lot Quality Inspection";
    begin
        // 1. Enforce FDA 21 CFR Part 11 Dual Authentication
        if not UserSetup.Get(InspectorUserID) then
            Error('FDA Audit Error: User %1 is not authorized as a Quality Inspector.', InspectorUserID);

        if not UserSetup."Is Quality Inspector Authorized" then
            Error('FDA Audit Error: Inspector %1 lacks FDA Sign-off Security Role.', InspectorUserID);

        // 2. Lock Batch & Update Status
        if BatchQualityRecord.Get(BatchNo) then begin
            BatchQualityRecord."Inspection Status" := BatchQualityRecord."Inspection Status"::Approved;
            BatchQualityRecord."Approved By Inspector" := InspectorUserID;
            BatchQualityRecord."E-Signature Timestamp" := CurrentDateTime;
            BatchQualityRecord.Modify(true);

            LogFDAAuditTrail(BatchNo, InspectorUserID, 'BATCH_APPROVED_FOR_RELEASE');
            exit(true);
        end;

        exit(false);
    end;

    local procedure LogFDAAuditTrail(BatchNo: Code[20]; UserID: Code[50]; ActionText: Text)
    var
        FDAAuditLog: Record "FDA Audit Log";
    begin
        FDAAuditLog.Init();
        FDAAuditLog."Log GUID" := CreateGuid();
        FDAAuditLog."Batch No." := BatchNo;
        FDAAuditLog."User ID" := UserID;
        FDAAuditLog."Action Description" := ActionText;
        FDAAuditLog."Timestamp" := CurrentDateTime;
        FDAAuditLog.Insert(true);
    end;
}